Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorChina Medical University Hospital

About this trial

The goal of this clinical trial is to learn if there benefits combine enhanced external counterpulsation (EECP) with the standard post-acute care (PAC) rehabilitation treatment to treat stroke patients.. The main questions it aims to answer are:

What is the feasibility of combining EECP and PAC? Does EECP combined PAC rehabilitation improve functional outcomes of post-stroke patients? Researchers will compare standard PAC rehabilitation and EECP combined PAC rehabilitation to see if EECP has benefits to treat stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with acute cerebrovascular disease, within 1 month after acute attack.

Stable medical condition: (1). Neurological condition: The neurological condition has not deteriorated for more than 72 hours. (2). Vital signs including blood pressure, heartbeat, and body temperature are stable or controllable for more than 72 hours. (3). No complications such as infection, blood abnormalities, gastrointestinal bleeding, or stable or controllable after treatment.

Those whose functional status is moderate to moderately severe functional impairment (MRS 3-4) and who are judged by the medical team to have active rehabilitation potential: (1). Have basic cognition, learning ability and willingness. (2) Have sufficient physical strength: able to maintain a sitting position on a wheelchair or bed edge for at least one hour with support. (3). Be able to actively participate in rehabilitation treatment plans.

Aged over 20 years old

Disqualifiers

Patients with atrial fibrillation/arrhythmia.

Within 2 weeks after cardiac catheterization or arterial puncture at the femoral artery puncture site.

Decompensated heart failure (NYHA class 3 or 4).

Left ventricular ejection fraction (EF) < 30%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • enhanced external counterpulsation

    Device

    Enhanced External Counterpulsation (EECP) is a non-invasive treatment primarily used for patients with angina or heart failure. It involves the application of pressure cuffs to the legs, which inflate and deflate in sync with the cardiac cycle. This enhances blood flow to the heart during diastole, the phase when the heart is resting between beats. The increased pressure promotes coronary artery perfusion, helping to improve oxygen delivery to the heart muscle, reduce angina symptoms, and enhance cardiovascular function. EECP is typically recommended for patients who are not good candidates for invasive procedures like angioplasty or bypass surgery, or for those seeking supplementary treatment for angina. Over time, it may promote the development of new blood vessels (collateral circulation), further improving heart health. The treatment is generally administered over several weeks in outpatient settings, with each session lasting around one hour.

  • post acute care

    Procedure/Surgery

    Post-Acute Care (PAC) for stroke patients focuses on improving functional independence, reducing disability, and preventing secondary complications.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: EECP+PACExperimental treatment 2 interventions
Group B: PACActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Rankin Scale (MRS)

A 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. It is used to categorize level of functional independence with reference to pre-stroke activities. Activity limitations are difficulties in performance of activities.It can be documented by the physician/APN/PA, nurse (RN), medical assistant, or any individual trained to perform the mRS.

Time frame
0, 3, 6, 9 weeks
2

Barthel Activity Daily Living Index

The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.

Time frame
0, 3, 6, 9 weeks
3

Lawton-Brody Instrumental Activity Daily Living scale

It consists of 8 questions including information about telephone use, meal preparation, shopping, doing daily household chores, laundry, getting on transportation, traveling, medication use and management of finances.

Time frame
0, 3, 6, 9 weeks
4

Functional Oral Intake Scale

The Functional Oral Intake Scale (FOIS) is a reliable and valid tool for assessing functional oral food and fluid intake in patients with oropharyngeal dysphagia (OD). Fois has seven levels, with higher levels indicating better swallowing function.

Time frame
0, 3, 6, 9 weeks

Secondary outcomes

1

ankle-brachial index

The ankle-brachial index test compares the blood pressure in the ankle with the blood pressure in the arm.

Time frame
0 and 9 weeks

Other outcomes

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